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FDA Import Refusal BFH-0800811-9/11/1F — Nuga Medical Co., Ltd.

Nuga Medical Co., Ltd. — FEI 3004006265

The FDA refused shipment BFH-0800811-9/11/1F from Nuga Medical Co., Ltd. (South Korea) on April 2, 2018. The refused product falls under Devices — PILLOW, CERVICAL (FOR MILD SLEEP APNEA). Cited charges: 341,3724 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 2, 2018
Country
South Korea
Product Category
Devices
Product Code
77MYB PILLOW, CERVICAL (FOR MILD SLEEP APNEA)
Charges
341,3724

Recent inspections

  • 1194084 (VAI Thu Dec 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1060124 (VAI Fri Jul 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 898365 (OAI Thu Aug 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • SCS-4617905-9/11/1 (Thu Apr 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-2964640-2/11/1 (Tue Sep 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • BFH-0801079-2/11/1 (Mon Apr 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • BFH-0800811-9/11/1B (Mon Apr 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • BFH-0800811-9/11/1A (Mon Apr 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources